—#181128

Product

Philips Brilliance iCT SP Computed Tomography X-Ray System; Model # 728311

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K060937
Affected lot / code info: Serial # 200044 Additional unit as off 5/22/20: 200026

Why it was recalled

The bolt affixing the cooling unit to the rotor was not tightened to specification on the Philips Brilliance iCT systems.

Root cause (FDA determination)

Process control

Action the firm took

Philips sent a Medical Device Correction-Urgent Field Safety Notice dated April 6, 2020 to all affected customers. The firm instructed customers to review the information with all members of the staff who need to be aware of the contents of the notice and to maintain a copy with the equipment in the Instructions for Use. Customers were directed to complete and return the form stating that they received, read, and understood the contents of the letter and have taken appropriate actions. URGENT - Field Safety Notice Medical Device Correction letter dated 5/20/20 was sent to customers informing them of two additional affected systems. There is no action required by the customer. Testing and engineering analysis demonstrate that the under-torqued bolts do not pose any immediate safety risk as the mechanical connection between the cooling unit and the rotor continues to meet applicable safety standards. The affected systems may continue to be used according to the IFU. Philips is distributing this FSN to all affected customers/users and will correct the issue via Field Change Order FCO 72800725. Urgent Field Safety Notice Medical Device Correction dated 5/20/20 was distributed to notify additional systems not previously included in the original notification. There is no action required by the customer. Testing and engineering analysis demonstrate that the under-torqued bolts do not pose any immediate safety risk as the mechanical connection between the cooling unit and the rotor continues to meet applicable safety standards. The affected systems may continue to be used according to the IFU. Philips is distributing this FSN to all affected customers/users and will correct the issue via Field Change Order FCO 72800725. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377, follow the prompts).

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Worldwide distribution including one unit distributed to Iowa.

Timeline

Recall initiated: 2020-04-06
Posted by FDA: 2020-05-06
Terminated: 2022-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #181128. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.